Avid Bioservices Inc (CDMO)

[entdoc]

senrex, take a deep breath. regretably, in my one-on-one discussions with Steve King I did not come away with a very gratifying feeling about Cotara. I asked him why on earth we have no data out of China for lung cancer after all this time, and he deflected the question with vague references to the poor quality of the trial designs there. I asked him specifically about the possible need for more Cotara PII and he hedged that one too, saying, when asked specifically, that what the trial number PII, PII_III) was did not matter so much as that the regulatory pathway was clearly defined. It sounded as if they would dearly love to find a home for the orphan. I told him if I were sitting on the FDA I would ask how we establish that Cotara-I131 delivered directly to tumor bulk is better than I131 alone without Cotara. He said he thought that Cotara did help get tumorcidal doses of I131 to tumor core. I muttered that the catheter might be able to do that too. I asked if a more "modern" construct of Cotara (DNA-histone seeking) MABs were in the pipeline, venturing that Cotara is kinda clunky. He said that one problem with a more streamlined missile is that its "pass through" is faster and more of a problem too.
We touched on the virtues of fully humanized vs. chimeric Bavi, and I told him that was the only area of difference I had with PThorpe, and SK backed up the inventor repeatedly by not only mentioning other chimeric MABs (Rutuxin) that seem to work "time and time again" in the same patient without causing allergic reactions. He said, "of course we wanted to construct all-human Bavi, and we did it". When asked about 2C3 he didn't have much of a response other than to say Affitec was moving forward with it in Russia. Amen